Study of Ticagrelor Versus Aspirin Treatment in Patients With Myocardial Injury Post Major Non-cardiac Surgery
NCT ID: NCT02291419
Last Updated: 2017-02-09
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
6 participants
INTERVENTIONAL
2015-07-31
2016-06-30
Brief Summary
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Data from current studies suggest that myocardial injury detected by minor elevations in troponin levels within 3 days after non-cardiac surgery may occur in 10-24% of patients and is associated with an increased risk of mortality at 30 days and 1 year. There are no current guidelines for care of patients with elevated troponin levels in the absence of acute coronary syndrome. This study will assess if the increased risk of these patients is modifiable by an anti-platelet medication and evaluate the safety of this medication.
Patients will be randomized in an open label fashion to receive ticagrelor (anti-platelet medication) or 81 mg. aspirin. Patients will be followed on study treatment for 12 months, with the last contact at one month post treatment discontinuation.
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Detailed Description
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Data from current studies suggest that myocardial injury detected by minor elevations in troponin levels within 3 days after non-cardiac surgery may occur in 10-24% of patients and is associated with an increased risk of mortality at 30 days and 1 year. There are no current guidelines for care of patients with elevated troponin levels in the absence of acute coronary syndrome (ACS) and it is not certain if this is a modifiable disease process. Ticagrelor is a direct, reversible inhibitor of the platelet P2Y12ADP-receptor. It has been shown to be superior to clopidogrel in the setting of ACS. The clinical benefit of treating patients with port-operative troponin elevation with antiplatelet agents remains unexplored. The short half-life of ticagrelor makes it favorable to use in this setting.
This is an open label, randomized, parallel group study comparing ticagrelor to aspirin in patients who experience troponin elevations post major non-cardiac surgery. Patients will be randomized in an open-label fashion to receive either ticagrelor 90 mg twice daily or aspirin 81 mg once daily. Patients will be followed for 13 months post randomization (12 months of treatment and a phone call 30 days after study drug discontinuation). The maximum duration of treatment will be 12 months.
Follow-up visits will occur at Month 1, Month 6, and Month 12. Phone calls will be made at Month 3, Month 9, and at 30 days after study drug discontinuation.
Up to 1000 patients with post-operative troponin elevation ≥2x ULN within first 7 postoperative days, will be enrolled in the study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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ticagrelor
ticagrelor 90mg bid
ticagrelor
ticagrelor 90 mg bid
aspirin
Patients in the aspirin arm will receive aspirin 81 mg daily orally
aspirin
aspirin 81 mg daily
Interventions
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ticagrelor
ticagrelor 90 mg bid
aspirin
aspirin 81 mg daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. A qualifying post-operative T or I troponin elevation (≥2x ULN of assay within 7 days of index surgery and during the index hospitalization).
3. Men and women ≥40 years of age if troponin elevation was identified as part of routine post-operative clinical care OR
4. Men and women ≥55 years of age if troponin elevation was identified post-operatively as part of screening for the study.
5. Undergone non-cardiac surgery requiring an overnight hospital stay.
6. Women of childbearing potential who are sexually active must have a negative pregnancy test at enrollment and agree to use adequate contraception from screening until 30 days after receiving the last dose of study drug.
7. Able to be randomized within 35 days following the index surgery.
Exclusion Criteria
2. Post-operative high-risk non-STEMI, defined as patients with elevated troponin with either:
1. active Ischemic EKG changes (≥2 mm of ST-segment depression in at least 2 adjacent leads)
2. ongoing hemodynamic instability thought to be ischemia mediated or
3. persistent anginal symptoms.
3. Planned or urgent coronary angiography/revascularization.
4. A current or ongoing indication for dual antiplatelet therapy (DAPT) as determined by the patient's physician.
5. History of intracranial hemorrhage
6. Bleeding disorder or active bleeding that prevents ticagrelor or aspirin administration.
7. Taking any of the following medications at the time of randomization: vitamin K antagonists, dabigatran, rivaroxaban, apixaban, edoxaban , fondaparinux, cilostazol, vorapaxar or LMWHs.
8. Renal dialysis.
9. Hepatic impairment with transaminase ≥3x ULN at time of randomization.
10. Known contra-indication for use of ticagrelor.
11. Estimated life expectancy of \<1 year.
12. Enrolled in another ongoing drug or device research protocol
13. A definite non-ischemic explanation for troponin elevation, such as myocarditis or pulmonary embolism.
14. A documented hypersensitivity to aspirin.
15. Hypersensitivity to ticagrelor or any component of the product.
16. Neurological or ophthalmic surgery during the index hospitalization.
17. Patients taking strong CYP3A inhibitors and/or CYP3A inducers that cannot be stopped for the course of the study.
40 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
The Cleveland Clinic
OTHER
Responsible Party
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Venu Menon
MD, FACC, FAHA, Director CICU, CEC-C5, Fellowship Program Cardiovascular Imaging
Principal Investigators
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Venu Menon, MD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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University of South Alabama Health System
Mobile, Alabama, United States
Arkansas Site Management Service, LLC
Little Rock, Arkansas, United States
University of Florida College of Medicine - Jacksonville
Jacksonville, Florida, United States
Florida Hospital Orthopaedic Institute and Fracture Care Center
Orlando, Florida, United States
University of South Florida
Tampa, Florida, United States
Central Georgia Heart Center
Macon, Georgia, United States
Saint Vincent Medical Group
Indianapolis, Indiana, United States
University of Kentucky
Lexington, Kentucky, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
McLaren Bay Region
Bay City, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
McLaren Macomb
Mount Clemens, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
New York University School of Medicine
New York, New York, United States
Cincinnati VA Medical Center
Cincinnati, Ohio, United States
VA Medical Center - Cleveland Louis Stokes
Cleveland, Ohio, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Miami Valley Hospital
Dayton, Ohio, United States
Oklahoma Heart Institute
Tulsa, Oklahoma, United States
Oregon Health and Science University
Portland, Oregon, United States
VA North Texas Health Care System
Dallas, Texas, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
Overlake Hospital Medical Center
Bellevue, Washington, United States
Countries
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References
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Wallentin L, Becker RC, Budaj A, Cannon CP, Emanuelsson H, Held C, Horrow J, Husted S, James S, Katus H, Mahaffey KW, Scirica BM, Skene A, Steg PG, Storey RF, Harrington RA; PLATO Investigators; Freij A, Thorsen M. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2009 Sep 10;361(11):1045-57. doi: 10.1056/NEJMoa0904327. Epub 2009 Aug 30.
Vascular Events In Noncardiac Surgery Patients Cohort Evaluation (VISION) Study Investigators; Devereaux PJ, Chan MT, Alonso-Coello P, Walsh M, Berwanger O, Villar JC, Wang CY, Garutti RI, Jacka MJ, Sigamani A, Srinathan S, Biccard BM, Chow CK, Abraham V, Tiboni M, Pettit S, Szczeklik W, Lurati Buse G, Botto F, Guyatt G, Heels-Ansdell D, Sessler DI, Thorlund K, Garg AX, Mrkobrada M, Thomas S, Rodseth RN, Pearse RM, Thabane L, McQueen MJ, VanHelder T, Bhandari M, Bosch J, Kurz A, Polanczyk C, Malaga G, Nagele P, Le Manach Y, Leuwer M, Yusuf S. Association between postoperative troponin levels and 30-day mortality among patients undergoing noncardiac surgery. JAMA. 2012 Jun 6;307(21):2295-304. doi: 10.1001/jama.2012.5502.
POISE Study Group; Devereaux PJ, Yang H, Yusuf S, Guyatt G, Leslie K, Villar JC, Xavier D, Chrolavicius S, Greenspan L, Pogue J, Pais P, Liu L, Xu S, Malaga G, Avezum A, Chan M, Montori VM, Jacka M, Choi P. Effects of extended-release metoprolol succinate in patients undergoing non-cardiac surgery (POISE trial): a randomised controlled trial. Lancet. 2008 May 31;371(9627):1839-47. doi: 10.1016/S0140-6736(08)60601-7. Epub 2008 May 12.
Horr S, Reed G, Menon V. Troponin elevation after noncardiac surgery: Significance and management. Cleve Clin J Med. 2015 Sep;82(9):595-602. doi: 10.3949/ccjm.82a.15076.
Other Identifiers
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CCAZ-2014
Identifier Type: -
Identifier Source: org_study_id
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